Advertising medicines on the Internet and on social media – FDA and Federal Court of Justice

On 17 June 2014, the US Food and Drugs Administration (FDA) published drafts of two guidelines on advertising medicines and medical products on the Internet and social media. The first document dealt with advertising for which the available capacity (typical for Twitter or Google ads) is limited. The second document gives recommendations on how companies should correct false information about their products from third parties on the Internet if they in principle decide for such a correction.

If the advertiser on the Internet has only a limited number of characters available, these must, in the opinion of the FDA, provide clear, precise and accurate information about the risks of the products. They must at least include the name of the product, the area of application of a medicine, the most frequent risks and a hyperlink to further risks.

In Germany, the Federal Court of Justice handed down a less restrictive judgment on a similar case last year (BGH I ZR 2/12 of 6 June 2013). The court established legal criteria on the basis of the German Act on Advertising of Medicines (HWG) for advertising non-prescription medicines by means of Google AdWords. According thereto, the advertiser must integrate in the ad a clearly recognizable technically defect-free hyperlink directly to the warning required according to Sec. 4 ss. 3 HWG (“For risks and side effects read the instructions in the packaging and ask your doctor or chemist.”). In principle, the special characteristics of the advertising medium are to be taken into account from the point of view of the behaviour of the average user.

The FDA guidelines are drafts which are currently still under discussion. Even after the final version is available, the documents, as mere guidelines, will not be legally binding. However, it can be expected that they will have considerable practical effect in the USA. For Europe and Germany, it remains to be observed whether and to what extent the new US guidelines will affect the law on advertising medicines here.

In addition, in Germany, a one to one transfer of the judgment of the Federal Court of Justice on Google AdWords to social media cannot be assumed – in fact, each advertising media is to be assessed alone because of its special characteristics. Precisely in commenting and disseminating information by other users (“retweet” at Twitter or “share” and “like” at Facebook) active public advertising can arise from a (permitted) passive provision of information (prohibited in the case of prescription medicines). Even if users shorten or change information provided by the company, a liability risk of the company arises because it first provided the possibility of the dissemination.